Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0144-2014 — MLS Torpedo Mini-Light Ophthalmic single-port illumination. Sutureless 25- gauge illuminator for vitreo-retinal surgery when full field illumination of bimanual surgery if desired.

U.S. FDA — Device Enforcement · United States · 2013-06-27 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0144-2014
Date of alert: 2013-06-27
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Insight Instruments, Inc.
Product category: device
Product type: Devices

Reported risk: The product was registered and distributed as a Class I medical device and was subsequently determined to be a Class II medical device which requires FDA market clearance.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-0144-2014 — MLS Torpedo Mini-Light Ophthalmic single-port illumination. Sutureless 25- gauge illuminator for vitreo-retinal surgery when full field illumination of bimanual surgery if desired.

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